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Press releases published on September 8, 2025
Pasithea Therapeutics Announces Enrollment of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
-- Recommendation that trial escalate to next dose level of 8mg tablet -- -- Initial interim clinical data from first two cohorts expected in Q1 2026 -- MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the …
Picard Medical, Inc. Announces Presentation at H.C. Wainwright Global Investment Conference
TUCSON, Ariz., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), today announced that Patrick NJ Schnegelsberg, Chief Executive Officer, will present in-person at the H.C. Wainwright 27th Annual …
EDAP Receives HIFU Reimbursement for Prostate Cancer in France
Focal One Robotic HIFU procedure now covered under France’s national universal health system Reimbursement milestone allows increased patient access to Focal One Robotic HIFU AUSTIN, Texas, September 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader …
Attralus Presents New Data on Its Pan-Amyloid Diagnostic Imaging Candidates at ASNC 2025
124I-evuzamitide, the first pan-amyloid diagnostic imaging agent, demonstrated 100% sensitivity and specificity for the diagnosis of cardiac amyloidosis in patients suspected of or diagnosed with cardiac amyloidosis in ATTR, AL, and other rare types of …
IMDX Enrolls First Patient in GraftAssureDx Clinical Trial and Welcomes New Hospital Participants
iMDx’s ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight …
Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025
Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared …
Dianthus Therapeutics Announces Positive Data for Claseprubart (DNTH103) from the Phase 2 MaGic Trial in Generalized Myasthenia Gravis, Supporting Its Potential Best-In-Class Profile
Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13 Claseprubart …
Ocular Therapeutix™ to Host Investor Day on September 30, 2025
Company to highlight ongoing AXPAXLI™ wet AMD registrational program, strategy and next steps in NPDR and DME, and global commercial opportunity for AXPAXLI Event to feature global retinal disease experts Dr. Arshad M. Khanani MD, MA, FASRS; Professor …
Regeneron Advances Allergy Pipeline with Two Positive Phase 3 Trials Evaluating First-in-Class Antibody-Blockers of Cat and Birch Allergies
In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, …
Serina Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
HUNTSVILLE, AL, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, announced that Steve Ledger, Chief …
Rapport Announces Positive Topline Results from Phase 2a Clinical Trial of RAP-219 in Patients with Focal Onset Seizures
Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving seizure freedom for the 8-week treatment period (p<0. …
Stanford University Secures NIH Grant to Advance tiakis Biotech´s Elafin (Tiprelestat) Through a U.S. Phase II Trial in Pulmonary Arterial Hypertension
- Novel, disease-modifying treatment option for Pulmonary Arterial Hypertension (PAH), an orphan indication with a significant unmet medical need Kiel, GERMANY, September 8, 2025 – tiakis Biotech AG (“tiakis”), a clinical-stage biopharmaceutical company …
NRG Therapeutics Announces Oversubscribed £50m ($67m) Series B Financing to Deliver Clinical Data in Parkinson’s and Proof of Concept in ALS/MND
Oversubscribed £50m Series B led by SV Health Investors’ Dementia Discovery Fund, alongside other new investors British Business Bank, M Ventures, Novartis Venture Fund and Criteria Bio Ventures, together with existing investors Omega Funds and Brandon …
Leading Austrian Pathology Laboratory Group Chooses PathAI’s AISight® Dx to Accelerate Digital Pathology and Advanced Diagnostics
BOSTON and VIENNA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence and digital pathology solutions, today announced multi-year partnerships with a group of pioneering Austrian pathology laboratories to deploy AISight® …
ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The CE Mark certification allows marketing for both clinic and home use First commercial sales of the ARC-EX® System in …
Novonesis and Novo Nordisk will explore new solutions to improve metabolic health
Novonesis and Novo Nordisk join forces in a new research collaboration to explore solutions that seek to preserve and optimize metabolic health and well-being for people. COPENHAGEN, Denmark – September 8, 2025. Novonesis and Novo Nordisk has entered a …
AI-Powered Chest X-Rays Catch Hidden Lung Cancer Risks — Even When No One’s Looking
NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- A new clinical case study, presented today by Qure.ai and Hacettepe University, Turkey, at the IASLC World Conference on Lung Cancer 2025 in Barcelona, shows that Artificial Intelligence (AI) can detect …
CHARM Therapeutics Appoints Dr Erkut Bahceci as Chief Medical Officer
PRESS RELEASE CHARM Therapeutics Appoints Dr Erkut Bahceci as Chief Medical Officer LONDON – 8 September 2025 -- CHARM Therapeutics (“CHARM”, “The Company”), announces the appointment of Dr Erkut Bahceci as Chief Medical Officer. Erkut’s appointment …
Burning Rock Reports Second Quarter 2025 Financial Results
GUANGZHOU, China, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today …
InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore
BEIJING, Sept. 07, 2025 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA (orelabrutinib) has been approved by the Health Sciences …